Elana, Inc.

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    Manufacturers Product Number, 801-H  Lot/Serial Number, 160301
  • Classification du dispositif
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
  • Description du dispositif
    Elana Surgical KitHUD || The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

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  • Adresse du fabricant
    Elana, Inc., 10480 Little Patuxent Pkwy, Suite 400, Columbia MD 21044-3568
  • Source
    USFDA